MAY / JUN 2021
Pharma CDMOs investing more
Pharmaceutical CDMOs all over the world have been investing in differentiating capabilities in recent months . Lonza is to install three more lines at Visp , Switzerland ( pictured ), to manufacture the drug substance for Moderna ’ s COVID-19 vaccine . These will have the same capacity as the three existing lines and should be operational in early 2022 . The two firms agreed a ten-year strategic collaboration in May 2020 and Lonza had since added another line at Portsmouth , New Hampshire . Shortly before this , Lonza announced that it was to build a new , CHF 200 million small molecule complex at Visp , focusing on high potency treatments for cancer . This will cover about 2,000 m 2 , with six levels of manufacturing space . On completion , it will employ about 200 people and the firm is already recruiting . The first build-out will be a dedicated line for antibodydrug conjugate ( ADC ) payload molecules for an unnamed , global biopharmaceutical firm , which has made a major capital contribution to it . This should start operations in Q3 2023 . Further expansion possibilities are envisaged in drug substance , drug product and particle engineering technologies . Meanwhile , Carbogen Amcis is to build an extension at its main Bubendorf site , also in Switzerland , to make a complex , highly potent intermediate for a commercial ADC API for long standing Japan-based customer , who is contributing to the cost . The planning phase is under way and operations should commence in autumn 2022 . The facility will incorporate a new production line , with two 850 L reactors and an agitated filter dryer . It is designed for manufacturing up to Category 4 ( OEL < 1 µ g / m 3 ). Four other Carbogen Amcis sites – two in Switzerland , one in the UK and one in China – are also involved in manufacturing this intermediate . AMRI has invested in scale and handling capabilities to address orphan and rare disease products . Defined as those affecting fewer than 200,000 people in the US and fewer than one in 2,000 people in the EU , these accounted for 31 of the FDA ’ s 53 novel drug approvals in 2020 . They have been projected to grow at 12 %/ year in prescription sales to 2026 .
At its main site in Albany , New York , AMRI has added additional suites for 10-15 kg batches . At Grafton , Wisconsin , it has expanded its hydrogenation , filtering and drying and analytical capabilities , the latter including LC-MS and GC-MS instruments , as well as adding new experts . The company has also expanded at its site at Glasgow , UK . In India , Piramal Pharma Solutions ( PPS ) has acquired Hemmo Pharmaceuticals for about $ 106 million and earnouts linked to milestones . Hemmo is one of India ’ s largest manufacturers of synthetic peptides and one of the world ’ s few pure-play companies in this field , with R & D capabilities and a GMP-compliant facility . This will take PPS into peptide APIs for the first time . Also in peptides , CordenPharma has signed a Master Service Agreement to produce Revolo Biotherapeutics ’ first-in-class peptide and immune system resetting drug product , ‘ 1104 , to cGMP for Phase II clinical trials at its facility in Colorado . It also has capacity for commercial production of the API , which is targeted at aeosinophilic aesophagitis and allergic disease . Finally , following on from a strategic investment in December , Sterling Pharma Solutions has wholly acquired ADC Biotechnology , a UK specialist in bioconjugation for ADCs . A multi-million pound investment is planned to expand the technical and analytical services team , particularly in cGMP and establishing cGMP bioconjugation and ADC manufacturing at the Deeside site in 2022 .
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